Medtronic 2696 Patient Assistant Medical Device User Manual 2696 Technical Manual

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Date Submitted	2003-04-04 00:00:00
Date Available	2003-04-04 00:00:00
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Medtronic Confidential
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MODEL 2696 INCHECKTM
Patient Assistant
Physician’s manual
Investigational device.
/ Caution:
Limited by federal law (USA) to
investigational use.
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Explanation of symbols on the packaging and literature
Attention: See accompanying documentation
Type BF equipment
Battery polarity as shown
Serial number
Storage temperature
For United States audiences only
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician
only
Medical device
Telemetry (communication signal) status light lit
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Explanation of symbols on the device
Query button (Press to request implanted device
to check for AF)
AF?
OK symbol (AF is not present)
AF symbol (AF is present)
Therapy button (Press to instruct implanted
device to deliver atrial cardioversion therapy)
Record Symptoms button (Press to instruct the
implanted device to record cardiac activity)
Record symbol (recorded cardiac activity)
Type BF equipment
Low Batteries symbol
Battery polarity as shown
Attention: See accompanying documents
For United States audiences only
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician
only
220875001
Rev A
Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
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Table of contents
1 Description and intended use
2 Contents of the Patient Assistant box
2.1
2.2
Inspection
Installation and setup
3 Checking the patient’s heart rhythm
3.1
3.2
How to check the patient’s heart rhythm
Response when a query is requested
12
4 Requesting atrial cardioversion therapy
4.1
4.2
4.3
4.4
How to request cardioversion therapy
Response when therapy is requested
When the Therapy button will appear
If therapy is not delivered
16
5 Recording cardiac information
5.1
5.2
18
19
Replacement batteries
19
When to install batteries
19
How to install new batteries
20
7 Maintenance
7.1
7.2
7.3
17
How to record cardiac information
17
Response when record symptoms is requested
6 Battery information
6.1
6.2
6.3
13
13
15
16
21
Care and handling
Cleaning
22
Service
22
21
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7.4
Disposal
22
8 Troubleshooting
9 Specifications
9.1
9.2
23
25
Device specifications
25
Safety and compatibility standards
26
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Description and intended use
The Model 2696 InCheckTM Patient Assistant shown on Figure 1
is a hand-held, battery powered, radio frequency communication
device. The Patient Assistant communicates with certain
implantable Medtronic cardiac devices that provide patientactivated features. See the manual for the implanted device for
compatibility information.
The Patient Assistant can send simple programming commands
to the implanted device, and receive and display information about
the patient’s cardiac rhythm.
Telemetry status
light
AF?
Query button, press to check
for AT/AF episode detection
Symbol and button
display area
Record Symptoms
button, press to
record cardiac event
data
Wrist strap
connector
Figure 1. Patient Assistant (Not actual size)
Intended use – The Patient Assistant is intended for
unsupervised patient use away from a hospital or clinic. The
Patient Assistant activates one or more of the patient
management features in the implanted device, depending on the
implanted device model and the programmed features:
■
To verify whether the implanted device has detected a
suspected atrial arrhythmia.
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■
To initiate recording of cardiac event data in the implanted
device memory.
■
To request atrial cardioversion therapy, if supported by the
implanted device and patient activated therapy has been
previously programmed by the physician. Therapy is allowed
when the implanted device is currently detecting an atrial
arrhythmia episode and all conditions for delivering therapy
have been met.
Note:
■
Ventricular arrhythmia therapy cannot be patient activated
using the Patient Assistant.
Contents of the Patient Assistant box
The following should be found in the Patient Assistant box:
■
One Patient Assistant
■
Two N-size 1.5 V batteries
■
One carrying case
■
One wrist strap
■
One physician’s manual
■
One quick reference guide/patient ID card
■
Two warranty cards (USA and outside USA)
■
One patient manual
The Patient manual includes blank lines in sections 3 and 7 for the
patient’s prescription information. This information includes when
to use the Patient Assistant, which button to press and what
actions to take for each reply.
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The Quick Reference Guide/Patient ID Card provides a more
portable version of the basic instructions for using the Patient
Assistant. Blank lines are provided for name and telephone
number information.
2.1 Inspection
Inspect the Patient Assistant for damage or defects. If the case is
cracked or other defects are discovered, return the Patient
Assistant to Medtronic.
2.2 Installation and setup
Place new batteries in the Patient Assistant (see page 20).
Press either front panel button to test the Patient Assistant. The
telemetry status light flashes green for about 15 seconds, and the
Patient Assistant gives a short beep. This confirms that the
batteries can operate correctly.
Provide the necessary information in the Patient manual and
Quick Reference Guide/Patient ID Card.
Refer to the implantable device reference manual for information
about its features that apply to the Patient Assistant.
3.1
Checking the patient’s heart rhythm
How to check the patient’s heart rhythm
Note: The Patient Assistant may not communicate at full
strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).
1. Press the Query button. Verify that the telemetry status light
flashes green, and the Patient Assistant gives a short beep. If
these responses do not occur, see page 23.
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2. Place the Patient Assistant against the implanted device. See
Figure 2.
AF?
Figure 2. Positioning the Patient Assistant
3. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 3).
Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 3.
Note: Pressing the Therapy button will cause the implanted
device to deliver atrial cardioversion therapy. See page 16 for
information about when the Therapy button will appear.
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AF?
Figure 3. Patient Assistant with all symbols displayed for reference
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3.2 Response when a query is requested
The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.
Display
Definition
OK symbol: The implanted device is
not detecting an atrial
tachyarrhythmia episode.
AF symbol: The implanted device is
detecting an atrial tachyarrhythmia
episode.
Therapy button: Atrial cardioversion
therapy is allowed. See “Requesting
atrial cardioversion therapy” on
page 13 for more information.
Telemetry status light flashes
for about 15 seconds and
goes out.
The Patient Assistant did not
communicate with the implanted
device.
Low Batteries symbol: The Patient
Assistant batteries are low and should
be replaced soon.
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applicable table.
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Requesting atrial cardioversion therapy
4.1 How to request cardioversion therapy
Note: The Patient Assistant may not communicate at full
strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).
Note: Pressing the Therapy button will cause the implanted
device to deliver atrial cardioversion therapy. See page 16 for
information about when the Therapy button will appear.
1. Instruct the patient to sit down or lie down in a comfortable
position. Use the wrist strap if desired.
2. Press the Query button. Verify that the telemetry status light
flashes green, and the Patient Assistant gives a short beep. If
these responses do not occur, see page 23.
3. Place the Patient Assistant against the implanted device (see
Figure 4).
AF?
Figure 4. Positioning the Patient Assistant
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4. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 5).
Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 4.
5. Press the Therapy button (if lit after pressing the Query
button). The telemetry status light will flash red.
Note: The Therapy button will stay lit for about 10 seconds
after the query. If the Therapy button goes out before it can be
pressed, repeat steps 1 through 4.
6. Place the Patient Assistant against the implanted device.
7. Listen for a long beep and look to see if the telemetry status
light is solid red. Lift the Patient Assistant to see what appears
on the display area (Figure 5).
Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 7.
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AF?
Figure 5. Patient Assistant with all symbols displayed for reference
4.2 Response when therapy is requested
The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.
Display
Definition
OK symbol: The implanted device is not
detecting an atrial tachyarrhythmia
episode. Appears if the AF has stopped
since pressing the Query button.
AF symbol: The implanted device is
detecting an atrial tachyarrhythmia
episode.
(flashing)
Flashing Therapy button: Therapy will
be delivered soon. In most cases,
therapy will be delivered in about
10 seconds. The maximum time it takes
the implanted device to prepare to deliver
therapy is about 1 minute.
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Display
Definition
No Therapy button.
Therapy will not be delivered.
Telemetry status light is solid red with no
flashing button. See section 4.4.
Telemetry status light
flashes for about
15 seconds and goes out.
The Patient Assistant did not
communicate with the implanted device.
Low Batteries symbol: The Patient
Assistant batteries are low and should be
replaced soon.
4.3 When the Therapy button will appear
The Therapy button appears after pressing the Query button
when the following conditions are met:
■
The implanted device supports patient activated therapy.
■
Patient activated therapy is enabled in the implanted device.
■
The patient is in AT/AF.
■
All conditions to deliver atrial therapy are met.
4.4 If therapy is not delivered
If the Patient Assistant gives a long beep and the Therapy button
goes dark without flashing, the atrial cardioversion therapy was
cancelled before delivery. The typical reasons are:
■
The atrial rate cannot be confirmed.
■
The ventricular rate is too fast.
Refer to the reference manual for the implanted device for more
possible explanations and programming options.
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Recording cardiac information
5.1 How to record cardiac information
Note: The Patient Assistant may not communicate at full
strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).
1. Press the Record Symptoms button. Verify that the telemetry
status light flashes green, and the Patient Assistant gives a
short beep. If these responses do not occur, see
“Troubleshooting” on page 23.
2. Place the Patient Assistant against the implanted device. See
Figure 6.
AF?
Figure 6. Positioning the Patient Assistant
3. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 7).
Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 3.
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AF?
Figure 7. Patient Assistant with all symbols displayed for reference
5.2 Response when record symptoms
is requested
The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.
Display
Definition
Record symbol: The implanted device
successfully recorded heart rhythm
information.
Telemetry status light
flashes for about 15 seconds
and goes out.
The Patient Assistant did not
communicate with the implanted
device.
Low Batteries symbol: The Patient
Assistant batteries are low and should
be replaced soon.
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Battery information
6.1
Replacement batteries
The Patient Assistant operates with two N-size 1.5 volt batteries.
The recommended battery type is alkaline manganese dioxide,
type ANSI/NEDA 910A and IEC LR1. This battery is available
from the following manufacturers:
■
Duracell Model MN9100
■
Kodak Model KN
■
Rayovac Model RN-2
■
Panasonic Model AM5
■
Varta Model 4001
■
Energizer Model E90
These batteries can be purchased at a retail store, camera store,
battery speciality store, electronics store, or from an Internet
retailer.
6.2 When to install batteries
■
Install new batteries before giving the Patient Assistant to a
patient.
■
If the Low Batteries symbol appears, replace both batteries
soon. The Patient Assistant will operate for several more uses
after the initial appearance of the Low Batteries symbol.
Note: Follow local regulations for proper disposal of used
batteries.
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6.3
How to install new batteries
1. Slide the battery cover tab toward the center of the Patient
Assistant and push upward to open the battery compartment.
Figure 8. Replacing the batteries.
2. Remove the old batteries.
3. Insert the new batteries according to the polarity shown on the
battery compartment.
4. Snap the battery cover closed.
5. Verify that the Patient Assistant beeps and that the telemetry
status light flashes when the Query button or the Record
Symptoms button is pressed. This confirms that the new
batteries have sufficient charge to operate the Patient
Assistant.
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Maintenance
7.1 Care and handling
The Patient Assistant is designed for robust use, to be carried and
handled on a daily basis. However, it is a precision electronic
instrument and precautions should be taken to avoid damage.
To preserve battery life, remove the batteries when the Patient
Assistant is not used for long periods of time or exposed to
temperatures below 15 °C (60 °F).
Electronic devices are susceptible to many environmental
stresses. Precautions should be taken to avoid damage to the
unit, including (but not limited to) those listed here.
Precautions:
■
To prevent unintentional delivery of patient-activated therapy,
instruct your patient not to carry the Patient Assistant in a
pocket directly over the implanted device.
■
Do not immerse the Patient Assistant in liquid.
■
Do not clean the Patient Assistant with solvents or chlorine
based cleansers (for example, nail polish remover or bleach).
■
Do not drop the Patient Assistant or mishandle it in a way that
might physically damage the Patient Assistant.
■
Avoid spilling fluid on the Patient Assistant. Do not immerse in
liquid.
■
Do not open the Patient Assistant, except to install batteries.
■
Do not sterilize the device by gamma irradiation and do not
steam sterilize (autoclave) the Patient Assistant.
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■
Electromagnetic interference (EMI) can impair the proper
performance of the Patient Assistant. Normal operation can
be restored by moving away from the source of the
interference.
■
Other environmental factors may impact proper performance
of the Patient Assistant. Use of good electronic device
practices will help to prevent environmental damage to the
unit.
7.2 Cleaning
■
Be careful to prevent moisture from entering the Patient
Assistant. The Patient Assistant is moisture resistant, but not
waterproof.
■
Clean the outside of the Patient Assistant with a slightly damp
cloth. Mild household cleaners will not damage the case or
labels.
7.3 Service
The Medtronic Model 2696 InCheckTM Patient Assistant has been
carefully engineered, manufactured and quality tested to provide
long, trouble-free service. Should service or repair be necessary,
contact your local Medtronic representative at the appropriate
address or telephone number on the back cover of this document.
Please refer to the model number (Model 2696) and serial number
(located on the rear panel) when calling Medtronic.
7.4 Disposal
Follow local regulations for proper disposal of the Patient
Assistant at the end of its useful service life.
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Troubleshooting
The following list can be used to help solve possible problems with
the Model 2696 Patient Assistant.
Problem
Possible causes
Possible solutions
Telemetry status
light does not
flash, no beep.
The batteries are
inserted backwards.
Re-install the batteries.
The batteries are
depleted.
Replace the batteries.
Wrong type batteries. Verify that batteries are
N-size, 1.5 V.
Telemetry status
light flashes, no
beep.
A button is broken.
Replace the Patient
Assistant.
Component failure.
Replace the Patient
Assistant.
The speaker has
failed.
• Use response on the
display area.
• Replace Patient
Assistant.
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Problem
Possible causes
Possible solutions
Telemetry status
light stops flashing
without a response
after the button
press.
Insufficient telemetry.
Patient Assistant did
not communicate
with the implanted
device.
Reposition Patient
Assistant.
• Improve Patient
Assistant position over
implanted device.
• Circle the Patient
Assistant slowly over
the implanted device.
• Move away from the
source of interference.
Electromagnetic
interference.
Repeated failures
Patient Assistant is
outside its
temperature range:
8 °C (16 °F) to 43 °C
(110 °F).
Move to warmer or cooler
surroundings.
Patient Assistant
needs repair.
Contact a Medtronic
representative.
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Specifications
9.1 Device specifications
Dimensions: Approximately 96 mm x 56 mm x 22 mm
(3.77" x 2.20" x 0.86")
Power source: 2 N-size 1.5 volt batteries, alkaline (manganese
dioxide)
Battery dimensions: 10 mm diameter x 30 mm (0.39” x 1.18”)
Battery longevity: 180 uses minimum, when used once a day at
room temperature.1
Operating temperature: 8 °C (16 °F) to 43 °C
(110 °F)
Transport and storage (batteries not installed):
Ambient temperature: -40 °C (-40 °F) to 66 °C (150 °F)
Relative humidity: up to 95%
Audible output level: 65 dBA minimum at 96 mm (6")
Classification with respect to electric shock: Internally
powered
Protection from electric shock (IEC 60601-1): Type BF
Protection against ingress of liquids: Ordinary equipment
Mode of operation: Short term
Operating the Patient Assistant below 15 °C (60 °F) for extended
periods of time will shorten battery longevity
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9.2 Safety and compatibility standards
The Model 2696 Patient Assistant complies with the following
standards:
IEC 60601-1, Medical electrical equipment safety
IEC 60601-1-2, Electromagnetic compatibility
EN45502-1, Safety, marking and information of medical devices
This device complies with Part 15 of the FCC Rules. Operation
is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
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Medtronic Confidential
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Sales offices:
Asia: Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza,
The Lee Gardens, 33 Hysan Avenue,
Causeway Bay, Hong Kong
Tel. 852-2891-4068 Fax 852-2591-0313
Medtronic Asia Ltd.
3 Floor Peter Building,
570-6 Shinsa-Dong Kangnam-ku,
Seoul 135-120, South Korea
Tel. 82-2-548-1148 Fax 82-2-518-4786
Australia: Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road, Gladesville NSW 2111
Tel. 02-9879-5999 Fax 02-9879-5100
Austria: Medtronic Österreich GmbH
Millennium Tower, Handelskai 94-96,
1200 Vienna
Tel. 01-24044 Fax 01-24044-100
Belgium: Medtronic Belgium S.A.
Boechoutlaan 55, 1853 Strombeek-Bever
Tel. 02-456-0900 Fax 02-460-2667
Canada: Medtronic of Canada Ltd.
6733 Kitimat Road, Mississauga,
Ontario L5N 1W3
Tel. 905-826-6020 Fax 905-826-6620
Denmark: Medtronic-ViCare A/S
Birkerød Kongevej 150B, DK-3460 Birkerød
Tel. 45-823366 Fax 45-823365
Finland: Medtronic Finland OY/LTD
Sahaajankatu 24, PO Box 230,
FIN-00810 Helsinki
Tel. 9-755-2500 Fax 9-755-25018
France: Medtronic France S.A.S.
122, avenue du Général Leclerc,
92514 Boulogne-Billancourt Cedex
Tel. 01-5538-1700 Fax 01-5538-1800
Germany: Medtronic GmbH
Emanuel-Leutze-Straße 20, 40547 Düsseldorf,
PO Box 110738
Tel. 0211-52930 Fax 0211-5293100
Osterfeldstraße 86, 85737 Ismaning,
Tel. 089-321-4000 Fax 089-321-40010
Willhoop 1, 22453 Hamburg
Tel. 040-554-9480 Fax 040-554-94822
Leipziger Chaussee 191g, 06112 Halle/Saale
Tel. 0345-58081-11 Fax 0345-58081-22
220875001
Rev A
Greece: Medtronic Hellas S.A.
Agias Varvaras 5, 15231 Halandri, Athens
Tel. 30-2-10-677-9099 Fax 30-2-10-677-9399
Italy: Medtronic Italia SpA
Viale Fulvio Testi, 280 - Scala A, 20126 Milano
Tel. 02-661641 Fax 02-6427488
Via Lucrezio Caro, 63, 00193 Roma
Tel. 06-328141 Fax 06-3215812
Japan: Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku,
Kawasaki, Kanagawa 210-0913
Tel. 044-540-6112 Fax 044-540-6200
Latin America Headquarters: Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604 USA
Tel. 763-514-4000 Fax 763-514-4879
The Netherlands: Medtronic B.V.
Earl Bakkenstraat 10, PO Box 2542,
6401 DA Heerlen
Tel. 031-45-566-8000 Fax 031-45-566-8668
Norway: Medtronic Vingmed AS
Fjordveien 1, Postboks 366, 1323 Høvik
Tel. 67-580680 Fax 67-101212
Portugal: Medical Implant Portugal, Lda.
Rua Tomás da Fonseca,
Torre E 8, andar A,B, 1600 - 209 Lisboa
Tel. 21-724-5100 Fax 21-724-5199
Spain: Medtronic Ibérica, S.A.
Centro Empresarial Miniparc III, Edificio K,
Calle Caléndula, 93, El Soto de la Moraleja,
28109 Alcobendas – Madrid
Tel. 91-625-0400 Fax 91-650-7410
Sweden: Medtronic AB
Dackevägen 33, Box 265, S-177 25 Järfälla
Tel. 08-5222-0000 Fax 08-5222-0050
Switzerland: Medtronic (Schweiz) AG
Route du Molliau 31, Case Postale 84,
CH-1131 Tolochenaz
Tel. 41-21-803-8000 Fax 41-21-803-8099
U.K. and Ireland: Medtronic U.K. Ltd.
Suite 1, Sherbourne House,
Croxley Business Center, Watford,
Herts WD1 8YE, United Kingdom
Tel. 1923-212213 Fax 1923-241004
Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
Medtronic Confidential
implant_R02
220875_bcv.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. 1-763-514-4000
Fax 1-763-514-4879
Medtronic E.C. Authorized
Representative/Distributed by
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-45-566-8000
Fax 31-45-566-8668
Europe/Africa/Middle East
Headquarters
Medtronic Europe Sàrl
Route du Molliau 31
Case Postale
CH-1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. 41-21-802-7000
Fax 41-21-802-7900
*220875001*
220875001
Rev A
© Medtronic, Inc. 2003
All Rights Reserved
220875001
March 2003
Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.

---

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Subject                         : Model 2696,
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Metadata Date                   : 2003:04:04 21:59:14-08:00
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